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2 months ago
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Clinical Project Leader


General Electric
Location: UK
Job type: Permanent
Sector: Sciences
Category: General Engineering Jobs
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About Us:
GE is the world’s Digital Industrial Company, transforming industry with software-defined machines and solutions that are connected, responsive and predictive. Through our people, leadership development, services, technology and scale, GE delivers better outcomes for global customers by speaking the language of industry.

It is not about your career… it is not about your job title… it is about who you are…. It is about the impact you are going to make on the world. You want to go into uncharted waters… do things that haven’t been done to make yours and someone else's life better. GE has been doing that for decades! We will continue to do so! We are the world’s digital industrial company.

There is no other life sciences company quite like GE Healthcare Life Sciences. A $5 billion business with more than 11,000 individuals in over 100 countries, we are at work enabling a new era in medicine. For more than 60 years, GE Healthcare Life Sciences has globally supported the development and use of new therapies, helping accelerate the journey from biological understanding to clinical therapy. GE Healthcare Life Sciences works with cutting edge technology enabling and advancing the discovery, diagnosis and medical treatments of the present and the future. We are accelerating biology to cell therapy in ways no other company can.

Follow us on Facebook and Twitter and watch our discoveries in action on our YouTube channel.

Learn More About GE Healthcare Life Sciences

Learn More About Careers at GE Healthcare – Life Sciences

GE is committed to taking on the world’s toughest challenges. In order to fulfill that promise we rely on a culture of leadership, diversity and inclusiveness. We aim to employ the world’s brightest minds to help us create a limitless source of ideas and opportunities. We believe in hiring talented people of varied backgrounds, experiences and styles…people like you!

Role Summary:
Plan, monitor, and coordinate clinical research studies at external trial sites in compliance with Good Clinical Practice, Standard Operating Procedures, and Corporate Policies, Guidelines and Standards.

Essential Responsibilities:

* Participate in selection process of external Service Providers (SPs)

* Build a general understanding of our SPs, their organization and capabilities to anticipate opportunities & risks

* Translate technical requirements from R&D project teams into scope of work for execution by SPs.

* Build strong relationships to maximize performance and value delivered by SPs

* Create a culture of joint accountability to ensure Vendor performance

* Develop, maintain and share Good Vendor Management Practices

* Facilitate efficient and collaborative resolution of problems and conflicts with SPs and on behalf of SPs within Life Sciences.

* Facilitate final quality check for all operational processes associated with specific engagements and accountable for aligning engagement deliverables to GEHC policies and procedures for operations, compliance, and outsourcing

* Facilitate vendor training on applicable GEHC SOPs

* Performs initial contact and participates in the assessment and selection of qualified investigators for inclusion in clinical programs.

* Performs Pre-Selection, Initiation, Monitoring, and Closeout site visits.

* Contributes to the preparation of study documentation such as protocols, amendments, Case Report Forms, and study reports

* Collects and processes regulatory documents and correspondence.

* Negotiates and tracks center/trial budget according to financial agreement with each centre

* Assists in the tracking of subject enrollment at each trial site, and provides management with detailed reports of clinical activities, as requested

* Ensures that clinical trial sites have adequate supplies to perform the trial

* May supervise the work of more junior Clinical Research Associates

Qualifications/Requirements:

* Masters degree in a science related field with experience with clinical trials management within the healthcare industry or BSc, with experience in monitoring clinical trials

* Excellent prior knowledge of all aspects of the clinical trial process including planning, execution and reporting/publication of results

* Proven communication skills, both written and verbal, at all levels of an organization

* Must be willing to travel as required

Applications from job seekers who require sponsorship to work in the UK are welcome and will be considered alongside all other applications. However, non-EU/EEA candidates may not be appointed to a post if a suitably qualified, experienced and skilled EU/EEA candidate is available to take up the post, as the employing body is unlikely, in these circumstances, to satisfy the Resident Labour Market Test. For further information please visit the UK Border Agency website

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Desired Characteristics:

* Excellent communication and interpersonal skills

* Well organized and structured, attention to detail

* Ability to work independently and systematically

* Diplomatic, cooperative teamworker

Locations: United Kingdom; UK

GE offers a great work environment, professional development, challenging careers, and competitive compensation. GE is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
About Us:
GE is the world’s Digital Industrial Company, transforming industry with software-defined machines and solutions that are connected, responsive and predictive. Through our people, leadership development, services, technology and scale, GE delivers better outcomes for global customers by speaking the language of industry.

It is not about your career… it is not about your job title… it is about who you are…. It is about the impact you are going to make on the world. You want to go into uncharted waters… do things that haven’t been done to make yours and someone else's life better. GE has been doing that for decades! We will continue to do so! We are the world’s digital industrial company.

There is no other life sciences company quite like GE Healthcare Life Sciences. A $5 billion business with more than 11,000 individuals in over 100 countries, we are at work enabling a new era in medicine. For more than 60 years, GE Healthcare Life Sciences has globally supported the development and use of new therapies, helping accelerate the journey from biological understanding to clinical therapy. GE Healthcare Life Sciences works with cutting edge technology enabling and advancing the discovery, diagnosis and medical treatments of the present and the future. We are accelerating biology to cell therapy in ways no other company can.

Follow us on Facebook and Twitter and watch our discoveries in action on our YouTube channel.

Learn More About GE Healthcare Life Sciences

Learn More About Careers at GE Healthcare – Life Sciences

GE is committed to taking on the world’s toughest challenges. In order to fulfill that promise we rely on a culture of leadership, diversity and inclusiveness. We aim to employ the world’s brightest minds to help us create a limitless source of ideas and opportunities. We believe in hiring talented people of varied backgrounds, experiences and styles…people like you!

Role Summary:
Plan, monitor, and coordinate clinical research studies at external trial sites in compliance with Good Clinical Practice, Standard Operating Procedures, and Corporate Policies, Guidelines and Standards.

Essential Responsibilities:

* Participate in selection process of external Service Providers (SPs)

* Build a general understanding of our SPs, their organization and capabilities to anticipate opportunities & risks

* Translate technical requirements from R&D project teams into scope of work for execution by SPs.

* Build strong relationships to maximize performance and value delivered by SPs

* Create a culture of joint accountability to ensure Vendor performance

* Develop, maintain and share Good Vendor Management Practices

* Facilitate efficient and collaborative resolution of problems and conflicts with SPs and on behalf of SPs within Life Sciences.

* Facilitate final quality check for all operational processes associated with specific engagements and accountable for aligning engagement deliverables to GEHC policies and procedures for operations, compliance, and outsourcing

* Facilitate vendor training on applicable GEHC SOPs

* Performs initial contact and participates in the assessment and selection of qualified investigators for inclusion in clinical programs.

* Performs Pre-Selection, Initiation, Monitoring, and Closeout site visits.

* Contributes to the preparation of study documentation such as protocols, amendments, Case Report Forms, and study reports

* Collects and processes regulatory documents and correspondence.

* Negotiates and tracks center/trial budget according to financial agreement with each centre

* Assists in the tracking of subject enrollment at each trial site, and provides management with detailed reports of clinical activities, as requested

* Ensures that clinical trial sites have adequate supplies to perform the trial

* May supervise the work of more junior Clinical Research Associates

Qualifications/Requirements:

* Masters degree in a science related field with experience with clinical trials management within the healthcare industry or BSc, with experience in monitoring clinical trials

* Excellent prior knowledge of all aspects of the clinical trial process including planning, execution and reporting/publication of results

* Proven communication skills, both written and verbal, at all levels of an organization

* Must be willing to travel as required

Applications from job seekers who require sponsorship to work in the UK are welcome and will be considered alongside all other applications. However, non-EU/EEA candidates may not be appointed to a post if a suitably qualified, experienced and skilled EU/EEA candidate is available to take up the post, as the employing body is unlikely, in these circumstances, to satisfy the Resident Labour Market Test. For further information please visit the UK Border Agency website

javascript:void(0);

Desired Characteristics:

* Excellent communication and interpersonal skills

* Well organized and structured, attention to detail

* Ability to work independently and systematically

* Diplomatic, cooperative teamworker

Locations: United Kingdom; UK

GE offers a great work environment, professional development, challenging careers, and competitive compensation. GE is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
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